Chronic PainGET LivingNCT01974791
GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
A study testing GET Living in people with Chronic Pain and Neuralgia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Pain, Neuralgia, Musculoskeletal Pain
- What is being tested?
- GET Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pain-related fear (score >40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
- Musculoskeletal, neuropathic limb or back pain, or headache
- Functional limitations (score > 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).
Who cannot join
- Significant cognitive impairment (e.g., intellectual disability)
- Serious psychopathology (e.g., active suicidality).
- Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
- Systemic disease in active inflammatory state
- Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
- Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital Waltham
Waltham, Massachusetts, 02453
About this study
The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.
- Conditions
- Chronic Pain, Neuralgia, Musculoskeletal Pain, Headache
- Being tested
- GET Living
- Medical subject headings
- Chronic Pain, Neuralgia, Musculoskeletal Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GET LivingBehavioural
GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.
| Study group | Role | What they receive |
|---|---|---|
| GET Living Treatment | Experimental | Not described Receives: Behavioral: GET Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Fear of Pain
Measured: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
Secondary outcomes (5)
Decrease in Functional Disability
Measured: Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average
Improvement in School Functioning
Measured: Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average
Decrease in Pain Catastrophizing
Measured: Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average
Decrease in Pain Intensity
Measured: Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average
Increase in Physical Activity
Measured: Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Simons(Giardi), Boston Children's Hospital
- Investigators
- Laura E Simons, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974791
- Sponsor's protocol ID
- IRB-P00007276
- Other IDs
- 82267
- Acronym
- GET Living
- Status last verified
- Mar 2018
- First submitted
- 22 Oct 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simons LE, Harrison LE, Boothroyd DB, Parvathinathan G, Van Orden AR, O'Brien SF, Schofield D, Kraindler J, Shrestha R, Vlaeyen JWS, Wicksell RK. A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. Pain. 2024 Jan 1;165(1):177-191. doi: 10.1097/j.pain.0000000000003010. Epub 2023 Aug 25.
PubMed 37624900Schemer L, Hess CW, Van Orden AR, Birnie KA, Harrison LE, Glombiewski JA, Simons LE. Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. J Particip Med. 2023 Mar 9;15:e41292. doi: 10.2196/41292.
PubMed 36892929Beebe JA, Kronman C, Mahmud F, Basch M, Hogan M, Li E, Ploski C, Simons LE. Gait Variability and Relationships With Fear, Avoidance, and Pain in Adolescents With Chronic Pain. Phys Ther. 2021 Apr 4;101(4):pzab012. doi: 10.1093/ptj/pzab012.
PubMed 33482005
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
- ClinicalTrials.gov ID
- NCT01974791
- Acronym / sponsor ID
- GET Living / IRB-P00007276
- Conditions
- Chronic Pain, Neuralgia, Musculoskeletal Pain, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GET Living Treatment | Experimental | Behavioral: GET Living |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pain-related fear (score >40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
- Musculoskeletal, neuropathic limb or back pain, or headache
- Functional limitations (score > 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).
Key exclusion criteria (6 listed)
- Significant cognitive impairment (e.g., intellectual disability)
- Serious psychopathology (e.g., active suicidality).
- Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
- Systemic disease in active inflammatory state
- Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GET LivingGET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities. | Behavioural | GET Living Treatment |
Primary outcome
Decrease in Fear of Pain
Time frame: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
5 secondary outcomes
Decrease in Functional Disability
Time frame: Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average
Improvement in School Functioning
Time frame: Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average
Decrease in Pain Catastrophizing
Time frame: Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average
Decrease in Pain Intensity
Time frame: Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average
Increase in Physical Activity
Time frame: Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 37624900Simons LE, Harrison LE, Boothroyd DB, Parvathinathan G, Van Orden AR, O'Brien SF, Schofield D, Kraindler J, Shrestha R, Vlaeyen JWS, Wicksell RK. A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. Pain. 2024 Jan 1;165(1):177-191. doi: 10.1097/j.pain.0000000000003010. Epub 2023 Aug 25.
- Derived from this study: PubMed 36892929Schemer L, Hess CW, Van Orden AR, Birnie KA, Harrison LE, Glombiewski JA, Simons LE. Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. J Particip Med. 2023 Mar 9;15:e41292. doi: 10.2196/41292.
- Derived from this study: PubMed 33482005Beebe JA, Kronman C, Mahmud F, Basch M, Hogan M, Li E, Ploski C, Simons LE. Gait Variability and Relationships With Fear, Avoidance, and Pain in Adolescents With Chronic Pain. Phys Ther. 2021 Apr 4;101(4):pzab012. doi: 10.1093/ptj/pzab012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura E Simons, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GET Living in people with Chronic Pain and Neuralgia, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Fear of Pain (time frame: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974791, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.